VYVGART

Treatment must be initiated and supervised by a physician experienced in the management of patients with neuromuscular disorders. Posology Generalised myasthenia gravis The first treatment cycle and first administration of the second treatment cycle must be administered either by or under the supervision of a healthcare professional.

Subsequent treatment should be administered by a healthcare professional or may be administered at home by a patient or caregiver after adequate training in the subcutaneous injection technique. The recommended dose is 1 000 mg to be administered subcutaneously in cycles of once weekly injections for 4 weeks.

Subsequent treatment cycles should be administered according to clinical evaluation. 1). In the clinical development program, the earliest time to initiate a subsequent treatment cycle was 7 weeks from the initial infusion of the previous cycle.

For patients currently receiving efgartigimod alfa intravenously, the solution for subcutaneous injection may be used as an alternative. It is recommended to switch between formulations at the start of a new treatment cycle. No safety and efficacy data in patients switching formulations during the same cycle is available.

Chronic inflammatory demyelinating polyneuropathy The first 4 injections must be administered either by or under the supervision of a healthcare professional. Subsequent injections should be administered by a healthcare professional or may be administered at home by a patient or caregiver after adequate training in the subcutaneous injection technique.

The recommended dose is 1 000 mg administered subcutaneously as once- weekly injections. Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation. In case of worsening of symptoms, administration of once-weekly injections should be resumed.

For those patients transitioning from their current CIDP therapies, Vyvgart treatment should preferably be initiated before the clinical effect of these prior therapies starts to decrease. Clinical response is usually achieved within 3 months of initiation of treatment with efgartigimod alfa subcutaneous.

Clinical evaluation should be considered 3 to 6 months after treatment initiation to assess the treatment effect and at regular intervals thereafter. Missed dose An interval of at least 3 days should be observed between two consecutive administrations.

5%). The overall safety profile of Vyvgart subcutaneous for both cyclic and continuous dose regimens was consistent with the known safety profile of the intravenous formulation. Tabulated list of adverse reactions Adverse reactions described in this section were identified in clinical trials and from post-marketing reports.

These reactions are presented by system organ class and preferred term. Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) or not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1. Adverse reactions System organ class Adverse reaction Frequency category Upper respiratory tract infections Very common Urinary tract infections Common Infections and infestations* Bronchitis Common Immune system disorders Anaphylactic reaction a Not known Gastrointestinal disorders Nausea b Common Musculoskeletal and connective tissue disorders Myalgia Common General disorders and administration site conditions* Injection site reactions c, d Very common Injury, poisoning and procedural complications* Procedural headache e Common * See paragraph “Description of selected adverse reactions” a From spontaneous post-marketing reporting with intravenous route of administration b From spontaneous post-marketing reporting.

c Subcutaneous administration only. g. injection site rash, injection site erythema, injection site pruritus, injection site pain) e Intravenous administration only. Description of selected adverse reactions Injection site reactions In the pooled dataset from two clinical studies in gMG with efgartigimod alfa subcutaneous (n = 168), all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation.

0% (n = 74)) of patients experienced an injection site reaction. 1% (63/74) of the patients. 5% (10/80) of patients with the second, third and fourth treatment cycle. In a pooled dataset from 2 clinical studies in patients with CIDP who received continuous administration of efgartigimod alfa subcutaneous the incidence of injection site reactions was 26% (61/235).

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. e. myasthenic crisis), defined as intubation with or without mechanical ventilation except in the setting of routine postoperative care, has not been studied.

5). 1). 8). Patients should be monitored for clinical signs and symptoms of infections during treatment with Vyvgart. In patients with an active infection, the benefit-risk of maintaining or withholding treatment with efgartigimod alfa should be considered until the infection has resolved.

If serious infections occur, delaying treatment with efgartigimod alfa should be considered until the infection has resolved. 8). These were mild to moderate. Cases of anaphylactic reaction have been reported with efgartigimod alfa intravenous in the post-marketing setting.

2). Patients should be monitored for 30 minutes after administration for clinical signs and symptoms of injection reactions. Should a reaction occur and based on the severity of the reaction, appropriate supportive measures should be initiated.

Subsequent injections may be cautiously administered, based on clinical evaluation. If an anaphylactic reaction is suspected, administration of Vyvgart should be immediately discontinued and appropriate medical treatment initiated. Patients should be informed of the signs and symptoms of hypersensitivity and anaphylactic reactions and advised to contact their healthcare professional immediately should they occur.

Immunisations All vaccines should be administered according to immunisation guidelines. The safety of immunisation with live or live-attenuated vaccines and the response to immunisation with these vaccines during treatment with efgartigimod alfa are unknown.

For patients that are being treated with efgartigimod alfa, vaccination with live or live-attenuated vaccines is generally not recommended. If vaccination with live or live-attenuated vaccines is required, these vaccines should be administered at least 4 weeks before treatment and at least 2 weeks after the last dose of efgartigimod alfa.

1.